Batches of high blood pressure drug recalled due to…

Another 25 batches of high blood pressure pills have been recalled over fears they contain an impurity that causes cancer.   

The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs used in Britain, said the move was ‘precautionary’.  

All of the affected medicines contain irbesartan, which is used to treat high blood pressure.

But they also have been found to have an impurity called (5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole).

Millions of Brits with high blood pressure  are prescribed irbesartan-based drugs every year.

Some of the contaminated pills have been on the market since December 2018, the MHRA revealed today.

It is the latest in a line of drug recalls of sartan-type medicines, which may have been exposed to cancer-causing chemicals in factories in China and India. 

Just last month the MHRA issued a recall notice for 31 batches of drugs containing the same impurity. 

The Government agency at the time claimed the affected batches contained azido-tetrazole, considered by some to be the world’s most explosive chemical.

The recall has only been issued to pharmacies and wholesalers so patients do not need to check their own medication.

The medicines watchdog said there is ‘no evidence’ that the chemical impurity has caused any harm to patients..

It urged Britons not to stop taking the affected drugs without consulting their GP because suddenly stopping can be risky. 

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a notice concerning 25 batches of Irbesartan-containing medicinal products

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a notice concerning 25 batches of Irbesartan-containing medicinal products

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a notice concerning 25 batches of Irbesartan-containing medicinal products

A patient has their blood pressure checked (PA)

A patient has their blood pressure checked (PA)

A patient has their blood pressure checked (PA)

They warned that suddenly stopping medication for high blood-pressure can be risky.  

Dr Alison Cave, MHRA chief safety officer, said: ‘Patient safety is at the heart of what we do.

‘We’re recalling batches of certain sartan-containing products as a precautionary measure while we continue our investigation.

‘It’s important that healthcare professionals check their stock to quarantine and return these batches.

‘If you’ve been taking one of the affected products, continue to take your medication.

‘Speak with your doctor or pharmacist before stopping any treatment, they can address any concerns and can advise you on the best course of action.

‘Previous recalls of these types of products in 2018, 2019 and June 2021 are part of an ongoing investigation.

‘The MHRA is working with other medicines regulators on this issue.’

TIMELINE OF COMMON BLOOD-PRESSURE DRUGS’ RECENT RECALLS 

2012 – The blood-pressure medication valsartan is thought to have been contaminated with the cancer-causing, rocket-fuel chemical NDMA as far back as 2012.

European regulators warned last year the medication’s main manufacturer in China – Zhejiang Huahai Pharmaceutical – changed its manufacturing process seven years ago, which may have been to blame.

July 5, 2018 – The UK recalled the drug over growing concerns.

Many EU authorities then followed suit.

The European Medicines Agency said it was working to establish how long, and at what levels, patients might have been exposed to NDMA.

July 17 – The US Food and Drug Administration ordered a ban on valsartan’s prescription.

July 30 – China’s National Health and Family Planning Commission said the drug must not be used for diagnosis or treatment.

January 3, 2019 – The Medicines and Healthcare products Regulatory Agency recalled thousands of medications containing the blood-pressure drug irbesartan over NDEA fears.

The government-run body issued an alert over four batches of the medication and pulled the products – made by Actavis, now known as Accord – as a ‘precautionary measure’.

June 2021 – Pharmacies stocking 31 batches of affected drugs — several different types of irbesartan and losartan — were told to pull them after the cancer-causing impurity was detected

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WHAT ARE THE IRBESARTAN AND LOSARTAN CONTAINING DRUGS THAT ARE AFFECTED? 
PRODUCT NAME  BATCH NUMBER(S)   SUPPLIER EXPIRY DATE  PACK SIZE 
Aprovel 75mg Film-Coated Tablets, EU/1/97/046/017 9A111  Aventis Pharma Limited T/A Sanofi  July 2022  28 
Aprovel 75mg Film-Coated Tablets, EU/1/97/046/017  9A118  Aventis Pharma Limited T/A Sanofi  Oct 2022  28 
Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788)  0R258  Aventis Pharma Limited T/A Sanofi  Jan 2023  28 
Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788)  0R855  Aventis Pharma Limited T/A Sanofi  Sep 2023  28 
Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788)  8R827  Aventis Pharma Limited T/A Sanofi  Oct 2021  28 
Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788)  9R217  Aventis Pharma Limited T/A Sanofi  Dec 2021  28 
Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788)  9R2N7  Aventis Pharma Limited T/A Sanofi  Aug 2022  28 
Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788)  9R40E  Aventis Pharma Limited T/A Sanofi  Aug 2022  28 
Aprovel 300mg Film-Coated Tablets, EU/1/97/046/027, (PLGB 04425/0789)  0R262  Aventis Pharma Limited T/A Sanofi  Jan 2023  28 
Aprovel 300mg Film-Coated Tablets, EU/1/97/046/027, (PLGB 04425/0789)  0R263  Aventis Pharma Limited T/A Sanofi  Jan 2023  28 
Aprovel 300mg Film-Coated Tablets, EU/1/97/046/027, (PLGB 04425/0789)  8R830  Aventis Pharma Limited T/A Sanofi  Oct 2021  28 
Aprovel 300mg Film-Coated Tablets, EU/1/97/046/027, (PLGB 04425/0789)  9R27A  Aventis Pharma Limited T/A Sanofi  Jun 2022  28 
Aprovel 300mg Film-Coated Tablets, EU/1/97/046/027, (PLGB 04425/0789)  9R2N9  Aventis Pharma Limited T/A Sanofi  Aug 2022  28 
Co-Aprovel 150mg/12.5mg Film-Coated Tablets, EU/1/98/086/012, (PLGB 04425/0791)  0R824  Aventis Pharma Limited T/A Sanofi  Apr 2023  28 
Co-Aprovel 300mg/12.5mg Film-Coated Tablets, EU/1/98/086/017, (PLGB 04425/0792)  0R16E  Aventis Pharma Limited T/A Sanofi  May 2023  28 
Co-Aprovel 300mg/12.5mg Film-Coated Tablets, EU/1/98/086/017, (PLGB 04425/0792)  0R2EL  Aventis Pharma Limited T/A Sanofi  Aug 2023  28 
Co-Aprovel 300mg/12.5mg Film-Coated Tablets, EU/1/98/086/017, (PLGB 04425/0792)  8R962  Aventis Pharma Limited T/A Sanofi  Oct 2021  28 
Irbesartan Zentiva 75mg Film-Coated Tablets, EU/1/06/376/017  9A111  Zentiva  Jul 2022  28 
Aprovel 150mg Film-Coated Tablets, EU/1/97/046/004  FT050  Doncaster Pharmaceuticals Group Ltd  Mar 2023  28 
Aprovel 75mg Film-Coated Tablets, EU/1/97/046/017  9A111  MPT Pharma Limited  Jul 2022  28 
Aprovel 75mg Film-Coated Tablets, EU/1/97/046/017  9A118  MPT Pharma Limited Oct 2022  28 
Co-Aprovel 300mg/12.5mg Film-Coated Tablets, EU/1/98/086/017  FT013  PCO Manufacturing Ltd Feb 2023  28 
Aprovel 150mg Film-Coated Tablets, EU/1/97/046/004, (PLGB 18799/3988)  FT050  Gowrie Laxmico Ltd T/A B&S Healthcare  Mar 2023  28 
Aprovel 150mg Film-Coated Tablets, EU/1/97/046/004, (PLGB 18799/3988)  FT050  Gowrie Laxmico Ltd T/A B&S Healthcare  Mar 2023  28 
Co-Aprovel 150mg/12.5mg Film-Coated Tablets, EU/1/98/086/001, (PLGB 18799/3984)  FT037  Gowrie Laxmico Ltd T/A B&S Healthcare  Feb 202  28 

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